Senior Director, Late Stage Cell Therapy Process Development
Sana Biotechnology, Inc.
June 24, 2026
On-site
Cambridge, MA
Operations
Responsibilities:
- Provide strategic, technical leadership for late-stage process development of a PSC-derived islet product for Type 1 diabetes.
- Build and manage a high-performing process development team to develop commercial-ready manufacturing processes.
- Partner with Research to develop 3D stem cell seed train and differentiation processes, integrating bioreactors plus automated/closed technologies; lead DP process-enabling studies (formulation, fill/finish, cryopreservation).
- Lead process characterization and validation using DoE and QbD; support process performance qualification (PPQ).
- Establish and execute comparability strategy for pivotal process changes.
- Enable technology transfer to CDMOs or internal manufacturing; provide technical input to ensure successful implementation.
- Author/review CMC sections of regulatory submissions (IND, BLA), and support regulatory Q&A and inspections.
- Collaborate with multidisciplinary teams to deliver pivotal and commercial CMC.
- Hire, mentor, and develop engineers; drive continuous improvement.
- Contribute to organization strategy and innovation/career development; champion company culture.
Qualifications:
- Ph.D. in Biochemical Engineering, Chemical Engineering, or related field; 10+ years in cell therapy process development (5+ years late-stage); 5+ years leadership.
- Hands-on experience with perfusion and single-use bioreactor systems across benchtop to pilot/production scales; closed/automated manufacturing technologies.
- Stem cell biology knowledge; 2D/3D expansion/differentiation; GMP raw material selection.
- Engineering principles plus DoE/QbD for bioreactor scale up/down model development.
- Risk/root-cause analysis tools (e.g., FMEA, Ishikawa).
- cGMP knowledge and regulatory expectations for commercial cell therapy/biologics.
- Experience supporting regulatory submissions, Q&A, audits/inspections; tech transfer of cell therapy processes.
- Strong influencing, matrixed fast-paced collaboration, and excellent written/verbal communication.
Preferred/Additional:
- 10+ years direct experience from pre-pivotal to commercial.
- Experience optimizing protocols to generate stem-cell derived islets.
- PSC differentiation at >10L in bioreactors.
- Media development knowledge (spent media analytics and raw material regulatory expectations).
- Knowledge of PAT and analytical methods for deep product characterization.
- Track record implementing novel cell therapy manufacturing technologies into GMP.
- Provide strategic, technical leadership for late-stage process development of a PSC-derived islet product for Type 1 diabetes.
- Build and manage a high-performing process development team to develop commercial-ready manufacturing processes.
- Partner with Research to develop 3D stem cell seed train and differentiation processes, integrating bioreactors plus automated/closed technologies; lead DP process-enabling studies (formulation, fill/finish, cryopreservation).
- Lead process characterization and validation using DoE and QbD; support process performance qualification (PPQ).
- Establish and execute comparability strategy for pivotal process changes.
- Enable technology transfer to CDMOs or internal manufacturing; provide technical input to ensure successful implementation.
- Author/review CMC sections of regulatory submissions (IND, BLA), and support regulatory Q&A and inspections.
- Collaborate with multidisciplinary teams to deliver pivotal and commercial CMC.
- Hire, mentor, and develop engineers; drive continuous improvement.
- Contribute to organization strategy and innovation/career development; champion company culture.
Qualifications:
- Ph.D. in Biochemical Engineering, Chemical Engineering, or related field; 10+ years in cell therapy process development (5+ years late-stage); 5+ years leadership.
- Hands-on experience with perfusion and single-use bioreactor systems across benchtop to pilot/production scales; closed/automated manufacturing technologies.
- Stem cell biology knowledge; 2D/3D expansion/differentiation; GMP raw material selection.
- Engineering principles plus DoE/QbD for bioreactor scale up/down model development.
- Risk/root-cause analysis tools (e.g., FMEA, Ishikawa).
- cGMP knowledge and regulatory expectations for commercial cell therapy/biologics.
- Experience supporting regulatory submissions, Q&A, audits/inspections; tech transfer of cell therapy processes.
- Strong influencing, matrixed fast-paced collaboration, and excellent written/verbal communication.
Preferred/Additional:
- 10+ years direct experience from pre-pivotal to commercial.
- Experience optimizing protocols to generate stem-cell derived islets.
- PSC differentiation at >10L in bioreactors.
- Media development knowledge (spent media analytics and raw material regulatory expectations).
- Knowledge of PAT and analytical methods for deep product characterization.
- Track record implementing novel cell therapy manufacturing technologies into GMP.